Project Engineer II
FORMULATED Solutions LLC
Summary
Completes engineering projects by organizing and controlling project elements such as scope development, cost estimation, detailed design, construction management, and project closeout meetings.
Job description
Primary Purpose
Completes engineering projects by organizing and controlling project elements such as scope development, cost estimation, detailed design, construction management, and project closeout meetings.
Major Duties and Responsibilities
- From a problem description, develop high-level scopes including USER REQUIREMENTS that provide solutions to the problem.
- Once high-level scopes are complete, develop order of magnitude (OOM) cost estimates for various solutions.
- Present solutions to Executive Management and get preliminary approval of design concepts before writing the capital request.
- Once approved, develop detailed design parameters for project design and implementation.
- Identify project responsibilities, delegating phases and elements to the appropriate personnel.
- Develop and control the full project plan lifecycle.
- Assist or act as the construction manager to deliver on project objectives and procedures.
- Prepare schedule and necessary updates of construction activities and analysis of manpower and equipment required.
- Monitor both schedule and cost versus approved scope.
- Prepare project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.
- Create and administer appropriate testing protocols (FAT, SAT, IOQ, etc) to ensure equipment and design performance.
- Inform all supervisors and subcontractors promptly of any construction schedule changes, and work closely with all stakeholders to ensure all USER REQUIREMENTS are met within budget and on time.
- Maintain budgetary, scheduling, and project database oversight.
- Ensure compliance of design and project implementation (OSHA, NEC, ASME, NFPA, etc) and adherence to site quality assurance standards and specifications.
Qualifications
- Required Bachelor's degree in Engineering or related field of study.
- Strong field management experience.
- Previous Project Engineering experience.
- Must be able to lift up to 20 pounds on a regular basis.
- Preferred: Additional background in or working knowledge of the Pharmaceutical industry and cGMP's preferable.
- Preferred: Chemical Manufacturing or Packaging Engineering experience is preferred.
- Preferred: Up-to-date Professional Engineer license.
Critical Skills and Abilities
- Strong working knowledge of design software, including AutoCAD, SOLIDWORKS, and CAD/CAM Circuit Design.
- Proven understanding of compliance and quality assurance guidelines and best practices.
Computer Skills
Ability to operate the following office equipment: computer, telephone, photocopier, facsimile, and calculator. PowerPoint, Word, Excel, and a basic understanding of Microsoft media applications is required.
Technical Skills and Experience
- Technical skills appropriate for the execution of technical transfers of topical products.
- Data analysis with a good understanding of statistical process control.
- PAT experience is preferred.
Physical Demands
- Must be able to lift and maneuver 40 pounds.
- Must be capable of standing for extended periods of time.
- Must be able to wear personal protection equipment, which includes gloves and a respirator, when required.
Requirements
- Bachelor's degree in Engineering or related field of study
- Strong field management experience
- Previous Project Engineering experience
- Must be able to lift up to 20 pounds on a regular basis
- Strong working knowledge of design software, including AutoCAD, SOLIDWORKS, and CAD/CAM Circuit Design
- Proven understanding of compliance and quality assurance guidelines and best practices
- Ability to operate office equipment: computer, telephone, photocopier, facsimile, and calculator
- PowerPoint, Word, Excel, and a basic understanding of Microsoft media applications
- Technical skills appropriate for the execution of technical transfers of topical products
- Data analysis with a good understanding of statistical process control
- Must be able to lift and maneuver 40 pounds
- Must be capable of standing for extended periods of time
- Must be able to wear personal protection equipment, which includes gloves and a respirator, when required
Company overview
FORMULATED Solutions LLC is a leading Contract Development and Manufacturing Organization (CDMO) specializing in pharmaceutical and consumer healthcare products. Founded in 1999, the company has grown from a product development consultancy into a comprehensive CDMO serving major consumer healthcare brands across the United States. With headquarters in Largo, Florida and a second facility in Cleveland, Tennessee, the company operates nearly 1 million square feet of pharmaceutical-grade manufacturing space. FORMULATED Solutions offers end-to-end services including innovation, formulation development, analytical testing, regulatory support, and scalable manufacturing for a wide range of product types including aerosols, pressurized packs, tubes, liquids, and semi-solids. The company serves markets including branded prescription drugs, over-the-counter medications, medical devices, and consumer healthcare products, with particular expertise in topical, nasal, rectal, and liquid oral dose formulations. Their proprietary eN2fused™ dispensing technology platform represents one of their key innovations in pressurized delivery systems.